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Regulatory Links

USA   Food and Drug Association (FDA)
Europe   European Union Drug Regulatory Agency (Eudra)
    Heads of Agencies for the European Union
UK   Medicines and Healthcare products Regulatory Agency (MHRA)
Germany   BfArM
Portugal   Instituto Nacional da Farmácia e do Medicamento
France   French Health Products Safety Agency
Spain   Agencia Española del Medicamento
Norway   Norway Medicines Board
Sweden   Medical Products Agency
Finland   National Agency for Medicines
Italy   Ministero della Salute
Netherlands   CBG
Australia   Therapeutic Goods Administration (TGA)
Bulgaria   Bulgarian Drug Agency
Canada   Therapeutic Products Directorate (TPD)
Chile   Chile Regulatory Agency
Russia   Czech Republic
Denmark   The Danish Medicines Agency
Estonia   State Agency of Medicines
Greece   EOD
Hong Kong   Hong Kong Department of Health Welfare and Food
India   Ministry of health and family welfare
Ireland   Irish Medicine Board
Japan   Ministry of Health, Labour and Welfare (MHLW)
Russia   Ministry of Health of the Russian Federation
Switzerland   Swiss Medic


FDA Home Page

FDA Freedom of Information Index

FDA Warning Letters

FDA Recalls

FDA Inspection Guides

FDA Compliance References

CFR Titles

U.S. Code

CBER Guidelines

CDER Guidelines

CDRH Guidelines

CDRH Documents


Investigation Operations Manual

FDA Medwatch (Medical Product Reporting Program)

FDA Phone Book (Staff Directory & Search Program for Employees of HHS-includes email addresses)

International Standards Organization

International Standards Organization

Medical Industry Associations

Parenteral Drug Association (PDA)

Institute of Validation Technology (IVT)

American Society of Quality (ASQ)

Intl. Society for Pharmaceutical Engineers (ISPE)

Pharmaceutical Research & Manufacturers of America (PHRMA)

Regulatory Affairs Professionals (RAPS)

Drug Information Association (DIA)

American Association of Pharmaceutical Scientists (AAPS)

Food & Drug Law Institute (FDLI)

Biotechnology Industry Association

Medical Device Manufacturers Association (MDMA)

Health Industry Manufacturers Association (HIMA)

Industry Publications & Publishers


Advanstar  (Pharmaceutical Executive & Pharmaceutical Technology Magazines)

Biopharm Magazine

F-D-C Reports (Green, Pink, Gold etc. Sheets)

Washington Information Source Company (Warning Letter Bulletin)

Medical Device Link (MDDI magazine)

The Member States - EU

 Protocol Order of EU Member State Flags 









België - Belgique


Czech Republic

République Tchèque

Česká Republika